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	<title>Symptom Advice .com &#187; initial treatment</title>
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		<title>What are the symptoms of psoriasis?. treatment methods?</title>
		<link>http://symptomadvice.com/what-are-the-symptoms-of-psoriasis-treatment-methods/</link>
		<comments>http://symptomadvice.com/what-are-the-symptoms-of-psoriasis-treatment-methods/#comments</comments>
		<pubDate>Wed, 16 Mar 2011 17:00:15 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[psoriasis symptoms]]></category>
		<category><![CDATA[initial treatment]]></category>
		<category><![CDATA[nails]]></category>
		<category><![CDATA[psoriasis]]></category>

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		<description><![CDATA[Hi, I &#104;&#097;&#118;&#101; symptoms of itching &#111;&#110; joints and silvery patches &#111;&#110; &#109;&#121; body. I &#104;&#097;&#118;&#101; consult &#116;&#104;&#101; doctor and he &#103;&#105;&#118;&#101; &#115;&#111;&#109;&#101; tablets. &#097;&#103;&#097;&#105;&#110; i &#104;&#097;&#118;&#101; &#116;&#104;&#101; problems. Can u &#116;&#101;&#108;&#108; &#109;&#101; &#116;&#104;&#101; treatment methods. &#116;&#104;&#101; doctor wrote &#116;&#104;&#101; prescription sheet as PSORIASIS P.D Currently &#116;&#104;&#101;&#114;&#101; &#105;&#115; &#110;&#111; cure for psoriasis. However, &#109;&#097;&#110;&#121; types [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2011/03/1300294815-19.jpg" style="clear:both;clear:both;margin:0 15px 15px 0;width:500px" />
<p>Hi,</p>
<p> I &#104;&#097;&#118;&#101; symptoms of itching &#111;&#110; joints and silvery patches &#111;&#110; &#109;&#121; body. I &#104;&#097;&#118;&#101; consult &#116;&#104;&#101; doctor and he &#103;&#105;&#118;&#101; &#115;&#111;&#109;&#101; tablets. &#097;&#103;&#097;&#105;&#110; i &#104;&#097;&#118;&#101; &#116;&#104;&#101; problems. Can u &#116;&#101;&#108;&#108; &#109;&#101; &#116;&#104;&#101; treatment methods. &#116;&#104;&#101; doctor wrote &#116;&#104;&#101; prescription sheet as PSORIASIS P.D</p>
<p>Currently &#116;&#104;&#101;&#114;&#101; &#105;&#115; &#110;&#111; cure for psoriasis. However, &#109;&#097;&#110;&#121; types of treatment &#097;&#114;&#101; &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101;, including products applied &#116;&#111; &#116;&#104;&#101; skin, phototherapy, and oral medications, that can keep psoriasis under control. &#109;&#111;&#115;&#116; cases &#097;&#114;&#101; mild and can be treated &#119;&#105;&#116;&#104; skin products. &#105;&#110; &#115;&#111;&#109;&#101; cases, psoriasis can be hard &#116;&#111; treat if it &#105;&#115; severe and widespread. &#109;&#111;&#115;&#116; psoriasis returns, &#101;&#118;&#101;&#110; mild forms.</p>
<p> Initial treatment</p>
<p> Treatment for mild psoriasis, characterized &#098;&#121; &#097; few isolated raised patches, &#098;&#101;&#103;&#105;&#110;&#115; &#119;&#105;&#116;&#104; skin care, &#119;&#104;&#105;&#099;&#104; includes keeping &#121;&#111;&#117;&#114; skin moist and lubricated. Basic treatment approaches often involve combinations of therapies and products that can usually be &#112;&#117;&#114;&#099;&#104;&#097;&#115;&#101;&#100; &#119;&#105;&#116;&#104;&#111;&#117;&#116; &#097; prescription, including:</p>
<p> * Creams, ointments, and lotions, &#116;&#111; lubricate &#116;&#104;&#101; skin.<br /> * Shampoos, oils, and sprays, &#116;&#111; treat psoriasis of &#116;&#104;&#101; scalp.<br /> * Ointments, &#116;&#111; treat psoriasis of &#116;&#104;&#101; nails.<br /> * &#115;&#111;&#109;&#101; exposure &#116;&#111; sunlight.</p>
<p> Ongoing treatment</p>
<p> Creams and ointments &#109;&#097;&#121; be &#117;&#115;&#101;&#100; &#105;&#110; combination &#119;&#105;&#116;&#104; sunlight or ultraviolet light (phototherapy) for moderate psoriasis that affects &#108;&#101;&#115;&#115; &#116;&#104;&#097;&#110; 20% of &#116;&#104;&#101; skin surface (about equal &#116;&#111; &#104;&#097;&#118;&#105;&#110;&#103; &#098;&#111;&#116;&#104; arms completely covered). However, creams, ointments, lotions, and topical (applied &#116;&#111; &#116;&#104;&#101; skin) medications work better for &#115;&#111;&#109;&#101; people &#116;&#104;&#097;&#110; for others. If one topical treatment does not clear up &#121;&#111;&#117;&#114; psoriasis, &#121;&#111;&#117;&#114; doctor &#119;&#105;&#108;&#108; likely recommend that you &#116;&#114;&#121; different combinations of treatments.</p>
<p> Treatment if &#116;&#104;&#101; condition &#103;&#101;&#116;&#115; worse</p>
<p> If you &#104;&#097;&#118;&#101; severe psoriasis, &#105;&#110; &#119;&#104;&#105;&#099;&#104; &#116;&#104;&#101; rash, or plaque, covers &#109;&#111;&#114;&#101; &#116;&#104;&#097;&#110; 20% of &#121;&#111;&#117;&#114; skin surface, &#121;&#111;&#117;&#114; doctor &#109;&#097;&#121; recommend systemic therapy. (Having &#098;&#111;&#116;&#104; &#121;&#111;&#117;&#114; arms completely covered &#119;&#105;&#116;&#104; plaque &#105;&#115; equivalent &#116;&#111; 20% of &#121;&#111;&#117;&#114; skin surface.) Systemic therapy involves &#116;&#104;&#101; use of medications such as retinoids, methotrexate, and cyclosporine, usually &#105;&#110; addition &#116;&#111; continued topical treatments and exposure &#116;&#111; ultraviolet light.</p>
<p>Some of &#116;&#104;&#101; symptoms of Psoriasis &#097;&#114;&#101; alos &#108;&#105;&#107;&#101; yours, but &#105;&#116;&#115; not &#115;&#117;&#114;&#101; &#097;&#098;&#111;&#117;&#116; yours, so you need detailed examination. <br /> You just &#116;&#114;&#121; &#115;&#111;&#109;&#101; ointments &#108;&#105;&#107;&#101; PANDERM, CANDID B etc, so that you can recover from this &#108;&#105;&#116;&#116;&#108;&#101; little itchng and patches. If not getting &#109;&#117;&#099;&#104; change &#097;&#102;&#116;&#101;&#114; that, better you go for &#109;&#111;&#114;&#101; consultation.</p>
<p> Dr. Friend</p>
<p>Currently &#116;&#104;&#101;&#114;&#101; &#105;&#115; &#110;&#111; cure for psoriasis. However, &#109;&#097;&#110;&#121; types of treatment &#097;&#114;&#101; &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101;, including products applied &#116;&#111; &#116;&#104;&#101; skin, phototherapy, and oral medications, that can keep psoriasis under control. &#109;&#111;&#115;&#116; cases &#097;&#114;&#101; mild and can be treated &#119;&#105;&#116;&#104; skin products. &#105;&#110; &#115;&#111;&#109;&#101; cases, psoriasis can be hard &#116;&#111; treat if it &#105;&#115; severe and widespread. &#109;&#111;&#115;&#116; psoriasis returns, &#101;&#118;&#101;&#110; mild forms.</p>
<p> The purpose of treatment &#105;&#115; &#116;&#111; slow &#116;&#104;&#101; rapid growth of skin cells that causes psoriasis and &#116;&#111; reduce inflammation. Treatment &#105;&#115; based &#111;&#110; &#116;&#104;&#101; type of psoriasis you &#104;&#097;&#118;&#101;, &#105;&#116;&#115; location, &#105;&#116;&#115; severity, and &#121;&#111;&#117;&#114; age and &#111;&#118;&#101;&#114;&#097;&#108;&#108; health. It &#097;&#108;&#115;&#111; depends &#111;&#110; how &#109;&#117;&#099;&#104; you &#097;&#114;&#101; affected &#098;&#121; &#116;&#104;&#101; condition, either physically (because of factors such as joint pain) or emotionally (because of embarrassment or frustration from &#097; skin rash that &#109;&#097;&#121; cover &#097; large or visible area of &#116;&#104;&#101; body).</p>
<p> Initial treatment<br /> Treatment for mild psoriasis, characterized &#098;&#121; &#097; few isolated raised patches, &#098;&#101;&#103;&#105;&#110;&#115; &#119;&#105;&#116;&#104; skin care, &#119;&#104;&#105;&#099;&#104; includes keeping &#121;&#111;&#117;&#114; skin moist and lubricated. Basic treatment approaches often involve combinations of therapies and products that can usually be &#112;&#117;&#114;&#099;&#104;&#097;&#115;&#101;&#100; &#119;&#105;&#116;&#104;&#111;&#117;&#116; &#097; prescription, including:</p>
<p> Creams, ointments, and lotions, &#116;&#111; lubricate &#116;&#104;&#101; skin. <br /> Shampoos, oils, and sprays, &#116;&#111; treat psoriasis of &#116;&#104;&#101; scalp. <br /> Ointments, &#116;&#111; treat psoriasis of &#116;&#104;&#101; nails. <br /> Some exposure &#116;&#111; sunlight.</p>
<p>Although we usually only consider Psoriasis &#097; skin condition, it can &#097;&#108;&#115;&#111; cause &#097; specific form of arthritis, and involvement &#119;&#105;&#116;&#104; &#116;&#104;&#101; fingernails or nail beds. Treatment &#105;&#115; dependent &#111;&#110; &#116;&#104;&#101; severity of &#116;&#104;&#101; condition. &#115;&#111;&#109;&#101; people benefit from sunlight or tanning beds (be careful not &#116;&#111; burn) and topical creams or lotions. &#109;&#105;&#110;&#101; &#103;&#111;&#116; better one time &#117;&#115;&#105;&#110;&#103; &#097; lotion &#119;&#105;&#116;&#104; colloidal oatmeal (like Aveeda)</p>
<p> If it &#105;&#115; &#109;&#111;&#114;&#101; severe, consult &#097; dermatologist. &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; &#115;&#111;&#109;&#101; very &#103;&#111;&#111;&#100; new treatments including &#097; new injection that has &#104;&#101;&#108;&#112;&#101;&#100; people that nothing else &#104;&#101;&#108;&#112;&#101;&#100; for years.</p>
<p>Homoeopathy and Naturopathy &#097;&#114;&#101; &#116;&#104;&#101; two methods &#116;&#111; cure psoriasis. &#116;&#104;&#101; combination of &#116;&#104;&#101;&#115;&#101; two &#104;&#101;&#108;&#112; curing it. But it &#109;&#097;&#121; take &#097; long time. Better avoid NV diet. Consume plenty of fresh vegetables &#108;&#105;&#107;&#101; carrot, cabbage and spinach. Take lot of carrot juice esp. &#105;&#110; &#101;&#109;&#112;&#116;&#121; stomach. Neem &#097;&#108;&#115;&#111; helps curing psoriasis (Please &#115;&#101;&#101; &#116;&#104;&#101; link below).</p></p>
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		<title>Longer-term Phase III data show Novartis drug Tasigna® continues to surpass Gleevec® in slowing disease progression in patients with newly diagnosed CML</title>
		<link>http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-gleevec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/</link>
		<comments>http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-gleevec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/#comments</comments>
		<pubDate>Mon, 06 Dec 2010 22:00:15 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[anorexia symptoms]]></category>
		<category><![CDATA[blast crisis]]></category>
		<category><![CDATA[initial treatment]]></category>

		<guid isPermaLink="false">http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-gleevec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/</guid>
		<description><![CDATA[Press Release Source: Novartis &#111;&#110; Monday December 6, 2010, 7:09 &#097;&#109; EST EAST HANOVER, N.J., Dec. 6, 2010 /PRNewswire/ &#8212; Fewer patients taking Tasigna &#102;&#111;&#114; Philadelphia chromosome-positive chronic myeloid leukemia &#105;&#110; chronic phase progressed &#116;&#111; advanced stages of the disease 24-month analysis confirms Tasigna induces deeper and &#109;&#111;&#114;&#101; durable cytogenetic and molecular responses Tasigna &#110;&#111;&#119; [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2010/12/1291672815-71.jpg%3Fw%3D400%26h%3D300" style="clear:both;clear:both;margin:0 15px 15px 0" /><strong>Press Release</strong> Source: Novartis &#111;&#110; Monday December 6, 2010, 7:09 &#097;&#109; EST
<p>EAST HANOVER, N.J., Dec. 6, 2010 /PRNewswire/ &#8212; </p>
<p>
<ul>
<li><i>Fewer patients taking Tasigna &#102;&#111;&#114; Philadelphia chromosome-positive chronic myeloid leukemia &#105;&#110; chronic phase progressed &#116;&#111; advanced stages of the disease </i></li>
</ul>
<p>
<ul>
<li><i>24-month analysis confirms Tasigna induces deeper and &#109;&#111;&#114;&#101; durable cytogenetic and molecular responses</i></li>
</ul>
<p>
<ul>
<li><i>Tasigna &#110;&#111;&#119; approved &#105;&#110; the US and Switzerland &#102;&#111;&#114; &#116;&#104;&#105;&#115; indication; regulatory submissions under review &#105;&#110; EU, Japan and &#111;&#116;&#104;&#101;&#114; countries worldwide</i></li>
</ul>
<p>Novartis announced today 24-month data &#115;&#104;&#111;&#119;&#105;&#110;&#103; that Tasigna® (nilotinib) 150 mg capsules continues &#116;&#111; surpass Gleevec® (imatinib mesylate) tablets* &#105;&#110; the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) &#105;&#110; chronic phase (1). These new data, from the first Phase III comparison of the two oral therapies &#097;&#115; initial treatment &#102;&#111;&#114; &#116;&#104;&#105;&#115; blood cancer, &#119;&#101;&#114;&#101; presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH) &#105;&#110; Orlando, Florida.</p>
<p>With &#116;&#104;&#105;&#115; longer-term follow-up at 24 months, first-line treatment with Tasigna at 300 mg twice daily &#119;&#097;&#115; &#102;&#111;&#117;&#110;&#100; &#116;&#111; result &#105;&#110; &#097; &#108;&#111;&#119;&#101;&#114; incidence of progression &#116;&#111; accelerated phase and blast crisis, compared &#116;&#111; the standard approved dose of Gleevec 400 mg &#111;&#110;&#099;&#101; daily. Patients receiving Tasigna &#097;&#108;&#115;&#111; &#104;&#097;&#100; &#097; &#108;&#111;&#119;&#101;&#114; incidence of suboptimal response and treatment failure &#097;&#115; defined &#098;&#121; study criteria (1).  </p>
<p>These data &#097;&#108;&#115;&#111; &#115;&#104;&#111;&#119;&#101;&#100; that Tasigna induced deeper and &#109;&#111;&#114;&#101; durable complete cytogenetic response (CCyR) and major molecular response (MMR) compared &#116;&#111; Gleevec, &#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; &#097; significantly higher rate of &#097;&#110; &#101;&#118;&#101;&#110; deeper response – &#097; trace &#097;&#109;&#111;&#117;&#110;&#116; of 0.0032% &#111;&#114; less of the Bcr-Abl protein that causes Ph+ CML, which is considered &#097; complete molecular response (CMR) (1). &#102;&#101;&#119;&#101;&#114; patients taking Tasigna &#105;&#110; the study discontinued treatment due &#116;&#111; adverse events compared &#116;&#111; Gleevec (1). Tasigna and Gleevec &#119;&#101;&#114;&#101; generally &#119;&#101;&#108;&#108; tolerated.</p>
<p>&#8220;These 24-month Phase III data extend the evidence of clinical benefit &#102;&#111;&#114; newly diagnosed patients with chronic phase Ph+ CML treated with Tasigna, compared &#116;&#111; Gleevec,&#8221; said Timothy P. Hughes, MD, ENESTnd study investigator and Clinical Professor at the University of Adelaide, Australia. &#8220;Now we &#099;&#097;&#110; begin &#116;&#111; evaluate the long-term treatment outcomes of patients who achieve and maintain deep reductions &#105;&#110; Bcr-Abl &#111;&#110; Tasigna.&#8221; </p>
<p>Rates of MMR and CCyR remain statistically higher &#102;&#111;&#114; Tasigna versus Gleevec at the 24-month minimum follow-up. MMR &#119;&#097;&#115; achieved &#098;&#121; 71% of patients taking Tasigna 300 mg twice daily and 67% of patients taking Tasigna 400 mg twice daily, compared &#116;&#111; 44% of patients taking Gleevec &#098;&#121; 24 months. Durable MMR rates &#119;&#101;&#114;&#101; statistically significantly higher &#105;&#110; the Tasigna 300 mg twice daily and Tasigna 400 mg twice daily arms compared &#116;&#111; Gleevec 400 mg &#111;&#110;&#099;&#101; daily (42%, 39% and 21% respectively). Significantly &#109;&#111;&#114;&#101; patients achieved CCyR &#105;&#110; the Tasigna 300 mg and 400 mg arms compared &#116;&#111; the Gleevec arm at 87% and 85% &#118;&#115;. 77% respectively &#098;&#121; 24 months. </p>
<p>The US Food and Drug Administration (FDA) and Swissmedic &#104;&#097;&#118;&#101; approved Tasigna &#105;&#110; &#116;&#104;&#105;&#115; first-line indication. &#105;&#110; September, Novartis received &#097; positive opinion from the Committee &#102;&#111;&#114; Medicinal Products &#102;&#111;&#114; Human &#117;&#115;&#101; (CHMP) recommending European Commission approval &#102;&#111;&#114; Tasigna &#102;&#111;&#114; &#116;&#104;&#105;&#115; indication. Regulatory submissions are under review &#105;&#110; the European Union, Japan and &#111;&#116;&#104;&#101;&#114; countries worldwide.</p>
<p>This year, Novartis &#097;&#108;&#115;&#111; began &#097; collaboration with molecular diagnostics company Cepheid &#116;&#111; develop &#097; new FDA cleared/approved Bcr-Abl test, which adheres &#116;&#111; the International Scale. The goal of the collaboration is &#116;&#111; &#104;&#101;&#108;&#112; doctors &#109;&#111;&#114;&#101; reliably monitor Ph+ CML patients. Cepheid and Novartis &#097;&#108;&#115;&#111; &#119;&#105;&#108;&#108; develop &#097; &#110;&#101;&#120;&#116; generation test, which is expected &#116;&#111; enable &#101;&#118;&#101;&#110; &#109;&#111;&#114;&#101; sensitive testing, indicating the depth of &#097; patient&#8217;s response &#116;&#111; tyrosine kinase inhibitors, including Tasigna and Gleevec. &#099;&#117;&#114;&#114;&#101;&#110;&#116;&#108;&#121; &#116;&#104;&#101;&#114;&#101; are no FDA cleared/approved tests &#116;&#111; monitor &#102;&#111;&#114; Bcr-Abl.</p>
<p>&#8220;The creation and introduction of Gleevec revolutionized the treatment of Ph+ CML &#098;&#121; substantially improving overall survival rates &#102;&#111;&#114; patients,&#8221; said Herve Hoppenot, President, Novartis Oncology. &#8220;We are encouraged &#098;&#121; the ongoing clinical development of Tasigna &#097;&#115; &#097; new treatment &#115;&#104;&#111;&#119;&#105;&#110;&#103; that at 24 months &#105;&#116; continues &#116;&#111; surpass Gleevec &#105;&#110; slowing disease progression &#105;&#110; patients with newly diagnosed chronic phase Ph+ CML.&#8221;</p>
<p>Another study &#119;&#105;&#108;&#108; &#098;&#101; presented at &#116;&#104;&#105;&#115; year&#8217;s annual ASH meeting which provides further support &#102;&#111;&#114; the &#117;&#115;&#101; of Tasigna &#105;&#110; patients with newly diagnosed Ph+ CML. The Gruppo Italiano Malattie Ematologiche dell&#8217;Adulto (GIMEMA) study, &#097;&#110; ongoing, open-label, single-stage, multicenter Phase II clinical trial, &#119;&#105;&#108;&#108; &#098;&#101; presented &#111;&#110; Monday, December 6, 2010 (2). </p>
<p><b>ENESTnd Study Details</b></p>
<p>The clinical trial, ENESTnd (<u>E</u>valuating <u>N</u>ilotinib <u>E</u>fficacy and <u>S</u>afety &#105;&#110; Clinical <u>T</u>rials of <u>N</u>ewly <u>D</u>iagnosed Ph+ CML Patients), is &#097; Phase III randomized, open-label, multicenter trial comparing the efficacy and safety of Tasigna versus Gleevec &#105;&#110; adult patients with newly diagnosed Ph+ CML &#105;&#110; chronic phase (1). &#105;&#116; is the &#108;&#097;&#114;&#103;&#101;&#115;&#116; global randomized comparison of two oral therapies ever conducted &#105;&#110; newly diagnosed Ph+ CML patients. </p>
<p>ENESTnd is &#098;&#101;&#105;&#110;&#103; conducted at 217 global sites with 846 patients enrolled. Patients &#119;&#101;&#114;&#101; randomized &#116;&#111; receive Tasigna 300 mg twice daily (n = 282), Tasigna 400 mg twice daily (n = 281) &#111;&#114; Gleevec 400 mg &#111;&#110;&#099;&#101; daily (n = 283). The primary endpoint &#119;&#097;&#115; MMR at 12 months; the key secondary endpoint &#119;&#097;&#115; durable MMR at 24 months (patients having MMR when evaluated at &#098;&#111;&#116;&#104; 12 and 24 months) (1). MMR &#119;&#097;&#115; defined &#105;&#110; the study &#097;&#115; reduction &#105;&#110; the level of the abnormal Bcr-Abl gene &#116;&#111; less &#116;&#104;&#097;&#110; &#111;&#114; equal &#116;&#111; 0.1% of the pretreatment level based &#111;&#110; &#097;&#110; internationally agreed standard (1). Planned follow-up is &#102;&#111;&#114; &#102;&#105;&#118;&#101; years. Patients &#111;&#110; the Gleevec treatment arm who &#104;&#097;&#100; suboptimal response &#111;&#114; treatment failure &#119;&#101;&#114;&#101; allowed &#116;&#111; escalate dose and/or switch &#116;&#111; Tasigna &#118;&#105;&#097; &#097; protocol extension. These data, presented at ASH, &#119;&#101;&#114;&#101; the 24-month minimum follow-up.</p>
<p>Results &#115;&#104;&#111;&#119;&#101;&#100; that &#102;&#101;&#119;&#101;&#114; patients progressed &#116;&#111; accelerated phase &#111;&#114; blast crisis while &#111;&#110; treatment with Tasigna at 300 mg twice daily (n = 2) and 400 mg twice daily (n = 3) versus Gleevec at 400 mg &#111;&#110;&#099;&#101; daily (n = 12) (1) with 24 months of minimum follow-up demonstrating &#097; significant improvement &#105;&#110; disease control. </p>
<p>These data &#097;&#108;&#115;&#111; &#115;&#104;&#111;&#119;&#101;&#100; that nearly &#116;&#104;&#114;&#101;&#101; times &#109;&#111;&#114;&#101; patients taking Tasigna 300 mg twice daily achieved CMR – defined &#097;&#115; &#097; trace &#097;&#109;&#111;&#117;&#110;&#116; of 0.0032% &#111;&#114; less of the Bcr-Abl protein that causes Ph+ CML – with Tasigna 300 mg twice daily (n = 70) &#116;&#104;&#097;&#110; with Gleevec (n = 25) &#098;&#121; 24-months (1). </p>
<p>All patients &#104;&#097;&#100; &#097; minimum of 24 months of treatment &#111;&#114; discontinued early; the median follow-up &#119;&#097;&#115; 25 months. Overall, 75%, 78% and 68% of patients remained &#105;&#110; the study &#111;&#110; Tasigna 300 mg twice daily, Tasigna 400 mg twice daily and Gleevec 400 mg &#111;&#110;&#099;&#101; daily, respectively (1). </p>
<p>Both Tasigna and Gleevec &#119;&#101;&#114;&#101; generally &#119;&#101;&#108;&#108; tolerated overall. Rates of discontinuation due &#116;&#111; adverse events &#111;&#114; laboratory abnormalities &#119;&#101;&#114;&#101; 9% &#102;&#111;&#114; Tasigna 300 mg twice daily, 13% &#102;&#111;&#114; Tasigna 400 mg twice daily and 11% &#102;&#111;&#114; Gleevec 400 mg &#111;&#110;&#099;&#101; daily (1). No patients treated with Tasigna &#105;&#110; the study &#104;&#097;&#100; prolongation of QT interval &gt;500 milliseconds (1). No sudden deaths occurred &#105;&#110; any of the treatment arms (1).</p>
<p><b>About Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)</b></p>
<p>Chronic myeloid leukemia is &#097; disease &#105;&#110; which the body produces cancerous white blood cells. Almost all patients with CML &#104;&#097;&#118;&#101; &#097;&#110; abnormality known &#097;&#115; the Philadelphia chromosome, which produces &#097; protein called Bcr-Abl. Bcr-Abl causes malignant white blood cells &#116;&#111; proliferate (3). Worldwide, CML is responsible &#102;&#111;&#114; approximately 10% &#116;&#111; 15% of all adult cases of leukemia (4), with &#097;&#110; incidence of one &#116;&#111; two cases &#112;&#101;&#114; 100,000 people &#112;&#101;&#114; year (5).</p>
<p><b>About Tasigna </b>(6)</p>
<p>Tasigna® (nilotinib) is indicated &#102;&#111;&#114; the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) &#105;&#110; chronic phase. The effectiveness of Tasigna is based &#111;&#110; major molecular response and cytogenetic response rates. The study is ongoing and further data &#119;&#105;&#108;&#108; &#098;&#101; required &#116;&#111; determine long-term outcome. </p>
<p>Tasigna is indicated &#102;&#111;&#114; the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) &#105;&#110; adult patients resistant &#111;&#114; intolerant &#116;&#111; prior therapy that included imatinib. The effectiveness of Tasigna is based &#111;&#110; hematologic and cytogenetic response rates<i>.</i> &#116;&#104;&#101;&#114;&#101; are no controlled trials demonstrating &#097; clinical benefit, &#115;&#117;&#099;&#104; &#097;&#115; improvement &#105;&#110; disease-related symptoms &#111;&#114; increased survival.</p>
<p>Tasigna &#104;&#097;&#115; &#098;&#101;&#101;&#110; approved &#105;&#110; &#109;&#111;&#114;&#101; &#116;&#104;&#097;&#110; 85 countries &#102;&#111;&#114; the treatment of chronic phase and accelerated phase Ph+ CML &#105;&#110; adult patients resistant &#111;&#114; intolerant &#116;&#111; at &#108;&#101;&#097;&#115;&#116; one prior therapy, including Gleevec. The effectiveness of Tasigna &#102;&#111;&#114; &#116;&#104;&#105;&#115; indication is based &#111;&#110; hematologic and cytogenetic response rates. &#116;&#104;&#101;&#114;&#101; are no controlled trials demonstrating &#097; clinical benefit, &#115;&#117;&#099;&#104; &#097;&#115; improvement &#105;&#110; disease-related symptoms &#111;&#114; increased survival.</p>
<p><b>Tasigna &#105;&#109;&#112;&#111;&#114;&#116;&#097;&#110;&#116; Safety Information</b></p>
<p><b>WARNING: QT PROLONGATION AND SUDDEN DEATHS </b></p>
<p><b>Tasigna prolongs the QT interval. Sudden deaths &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported &#105;&#110; patients receiving nilotinib. Tasigna &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101; &#117;&#115;&#101;&#100; &#105;&#110; patients with hypokalemia, hypomagnesemia, &#111;&#114; long QT syndrome. Hypokalemia &#111;&#114; hypomagnesemia &#109;&#117;&#115;&#116; &#098;&#101; corrected prior &#116;&#111; Tasigna administration and &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; periodically monitored. Drugs known &#116;&#111; prolong the QT interval and strong CYP3A4 inhibitors &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; avoided. Patients &#115;&#104;&#111;&#117;&#108;&#100; avoid food 2 hours &#098;&#101;&#102;&#111;&#114;&#101; and 1 hour &#097;&#102;&#116;&#101;&#114; taking dose. &#097; dose reduction is recommended &#105;&#110; patients with hepatic impairment. ECGs &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; obtained &#116;&#111; monitor the QTc at baseline, seven days &#097;&#102;&#116;&#101;&#114; initiation, and periodically &#116;&#104;&#101;&#114;&#101;&#097;&#102;&#116;&#101;&#114;, &#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; following any dose adjustments.</b></p>
<p><b>Contraindications </b></p>
<p>Do &#110;&#111;&#116; &#117;&#115;&#101; &#105;&#110; patients with hypokalemia, hypomagnesemia, &#111;&#114; long QT syndrome.</p>
<p><b>Warnings and Precautions </b></p>
<p><b>Myelosuppression</b></p>
<p>Treatment with Tasigna (nilotinib) &#099;&#097;&#110; &#099;&#097;&#117;&#115;&#101; Grade 3/4 thrombocytopenia, neutropenia and anemia. Perform complete blood counts every two weeks &#102;&#111;&#114; the first 2 months and then monthly &#116;&#104;&#101;&#114;&#101;&#097;&#102;&#116;&#101;&#114;, &#111;&#114; &#097;&#115; clinically indicated. Myelosuppression &#119;&#097;&#115; generally reversible and usually managed &#098;&#121; withholding Tasigna temporarily &#111;&#114; dose reduction.</p>
<p><b>QT Prolongation</b></p>
<p>Tasigna prolongs the QT interval.  ECGs &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; performed at baseline, seven days &#097;&#102;&#116;&#101;&#114; initiation, periodically &#097;&#115; clinically indicated, and following dose adjustments. Correct hypokalemia &#111;&#114; hypomagnesemia prior &#116;&#111; administration and monitor periodically. </p>
<p>Significant prolongation of the QT interval &#109;&#097;&#121; occur when Tasigna is inappropriately taken with food, and/or strong CYP3A4 inhibitors and/or medicinal products with &#097; known potential &#116;&#111; prolong QT. &#116;&#104;&#101;&#114;&#101;&#102;&#111;&#114;&#101;, co-administration with food &#109;&#117;&#115;&#116; &#098;&#101; avoided and concomitant &#117;&#115;&#101; with strong CYP3A4 inhibitors and/or medicinal products with &#097; known potential &#116;&#111; prolong QT &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; avoided. The presence of hypokalemia and hypomagnesemia &#109;&#097;&#121; further enhance &#116;&#104;&#105;&#115; effect.</p>
<p><b>Sudden Deaths</b></p>
<p>Sudden deaths &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported &#105;&#110; patients with resistant &#111;&#114; intolerant Ph+ CML receiving nilotinib (n = 867; 0.6%). &#097; similar incidence &#119;&#097;&#115; &#097;&#108;&#115;&#111; reported &#105;&#110; the expanded access program &#102;&#111;&#114; patients with resistance &#111;&#114; intolerant Ph+CML. The relative early occurrence of &#115;&#111;&#109;&#101; of these deaths relative &#116;&#111; the initiation of nilotinib suggests the possibility that ventricular repolarization abnormalities &#109;&#097;&#121; &#104;&#097;&#118;&#101; contributed &#116;&#111; &#116;&#104;&#101;&#105;&#114; occurrence. </p>
<p><b>Elevated Serum Lipase</b></p>
<p>Caution is recommended &#105;&#110; patients with &#097; history of pancreatitis. &#105;&#110; case lipase elevations are accompanied &#098;&#121; abdominal symptoms, doses &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; interrupted and appropriate diagnostics &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; considered &#116;&#111; exclude pancreatitis. Check serum lipase levels monthly &#111;&#114; &#097;&#115; clinically indicated.</p>
<p><b>Hepatotoxicity</b></p>
<p><u><i>Serum bilirubin and hepatic transaminases</i></u></p>
<p>The &#117;&#115;&#101; of Tasigna &#109;&#097;&#121; result &#105;&#110; elevations &#105;&#110; bilirubin, AST/ALT, and alkaline phosphatase. Hepatic function tests &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; checked monthly &#111;&#114; &#097;&#115; clinically indicated.</p>
<p><b>Electrolyte Abnormalities</b></p>
<p>Tasigna &#099;&#097;&#110; &#099;&#097;&#117;&#115;&#101; hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior &#116;&#111; initiating Tasigna and monitor periodically &#100;&#117;&#114;&#105;&#110;&#103; therapy.</p>
<p><b>Hepatic Impairment</b></p>
<p>Nilotinib exposure is increased &#105;&#110; patients with impaired hepatic function. &#097; &#108;&#111;&#119;&#101;&#114; starting dose is recommended &#102;&#111;&#114; patients with mild &#116;&#111; severe hepatic impairment and QT interval &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; monitored closely.</p>
<p><b>Drug Interactions</b><b> </b></p>
<p>The concomitant &#117;&#115;&#101; of QT prolonging drugs and strong inhibitors &#111;&#114; inducers of CYP3A4 &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; avoided &#097;&#115; &#116;&#104;&#101;&#121; &#109;&#097;&#121; affect serum concentration of Tasigna.</p>
<p><u><i>Concomitant strong CYP3A4 inhibitors</i></u></p>
<p>The concomitant &#117;&#115;&#101; of strong CYP3A4 inhibitors &#111;&#114; anti-arrhythmic drugs (including, &#098;&#117;&#116; &#110;&#111;&#116; limited &#116;&#111; amiodarone, disopyramide, procainamide, quinidine and sotalol) and &#111;&#116;&#104;&#101;&#114; drugs that &#109;&#097;&#121; prolong QT interval (including, &#098;&#117;&#116; &#110;&#111;&#116; limited &#116;&#111; chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, and pimozide) &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; avoided. &#115;&#104;&#111;&#117;&#108;&#100; treatment with any of these agents &#098;&#101; required, &#105;&#116; is recommended that therapy with Tasigna &#098;&#101; interrupted. If interruption of treatment with Tasigna is &#110;&#111;&#116; &#112;&#111;&#115;&#115;&#105;&#098;&#108;&#101;, patients who require treatment with &#097; drug that prolongs QT &#111;&#114; strongly inhibits CYP3A4 &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; closely monitored &#102;&#111;&#114; prolongation of the QT interval. If patients &#109;&#117;&#115;&#116; &#098;&#101; co-administered &#097; strong CYP3A4 inhibitor, based &#111;&#110; pharmacokinetic studies, &#099;&#111;&#110;&#115;&#105;&#100;&#101;&#114; &#097; dose reduction &#116;&#111; 300 mg &#111;&#110;&#099;&#101; daily &#105;&#110; patients with resistant &#111;&#114; intolerant Ph+ CML &#111;&#114; &#116;&#111; 200 mg &#111;&#110;&#099;&#101; daily &#105;&#110; patients with newly diagnosed Ph+ CML-CP. If the strong inhibitor is discontinued, &#097; washout period &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; allowed &#098;&#101;&#102;&#111;&#114;&#101; Tasigna is adjusted upward &#116;&#111; the indicated dose. Close monitoring &#102;&#111;&#114; prolongation of the QT interval is indicated &#102;&#111;&#114; patients who &#099;&#097;&#110;&#110;&#111;&#116; avoid strong CYP3A4 inhibitors. Grapefruit products and &#111;&#116;&#104;&#101;&#114; foods that are known &#116;&#111; inhibit CYP3A4 &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; &#098;&#101; avoided.</p>
<p><u><i>Concomitant strong CYP3A4 inducers</i></u></p>
<p>The concomitant &#117;&#115;&#101; of strong CYP3A4 inducers &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; avoided (including, &#098;&#117;&#116; &#110;&#111;&#116; limited &#116;&#111;, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital). Patients &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; refrain from taking St John&#8217;s Wort.   Based &#111;&#110; the nonlinear pharmacokinetic profile of nilotinib, increasing the dose of Tasigna when co-administered with &#115;&#117;&#099;&#104; agents is &#117;&#110;&#108;&#105;&#107;&#101;&#108;&#121; &#116;&#111; compensate &#102;&#111;&#114; the loss of exposure. Tasigna is &#097; competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and UGT1A1. &#105;&#110; vitro studies &#097;&#108;&#115;&#111; suggest that nilotinib &#109;&#097;&#121; induce CYP2B6, CYP2C8 and CYP2C9, and decrease the concentrations of drugs which are eliminated &#098;&#121; these enzymes. Single-dose administration of Tasigna &#116;&#111; healthy subjects &#100;&#105;&#100; &#110;&#111;&#116; change the pharmacokinetics and pharmacodynamics of warfarin (a CYP2C9 substrate). The ability of Tasigna &#116;&#111; induce metabolism &#104;&#097;&#115; &#110;&#111;&#116; &#098;&#101;&#101;&#110; determined &#105;&#110; vivo. Caution &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; exercised when co-administering Tasigna with substrates &#102;&#111;&#114; these enzymes that &#104;&#097;&#118;&#101; &#097; narrow therapeutic index. Tasigna inhibits human P-glycoprotein. If Tasigna is administered with drugs that are substrates of Pgp, increased concentrations of the substrate are likely and caution &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; exercised.</p>
<p><u><i>Proton pump inhibitors</i></u></p>
<p>Since proton pump inhibitors affect pH of the upper GI tract &#102;&#111;&#114; &#097;&#110; extended period, separation of doses &#109;&#097;&#121; &#110;&#111;&#116; eliminate the interaction, The concomitant &#117;&#115;&#101; of proton pump inhibitors with Tasigna &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; &#117;&#115;&#101;&#100; with caution. </p>
<p><b>Food Effects</b></p>
<p>Food increases blood levels of Tasigna. Patients &#115;&#104;&#111;&#117;&#108;&#100; avoid food  2 hours &#098;&#101;&#102;&#111;&#114;&#101; and at &#108;&#101;&#097;&#115;&#116; one hour &#097;&#102;&#116;&#101;&#114; the dose is taken. </p>
<p><b>Total Gastrectomy</b></p>
<p>The exposure of nilotinib is reduced &#105;&#110; patients with total gastrectomy.  More frequent follow-up of these patients &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; considered. Dose increase &#111;&#114; alternative therapy &#109;&#097;&#121; &#098;&#101; considered &#105;&#110; patients with total gastrectomy.  </p>
<p><b>Lactose</b></p>
<p>Since the capsules &#099;&#111;&#110;&#116;&#097;&#105;&#110; lactose, Tasigna is &#110;&#111;&#116; recommended &#102;&#111;&#114; patients with rare hereditary problems of galactose intolerance, severe lactose deficiency with &#097; severe degree of intolerance &#116;&#111; lactose-containing products, &#111;&#114; of glucose-galactose malabsorption.</p>
<p><b>Use &#105;&#110; Pregnancy</b><b> </b></p>
<p>There are no adequate and well-controlled studies of Tasigna &#105;&#110; pregnant women.  However, Tasigna &#109;&#097;&#121; &#099;&#097;&#117;&#115;&#101; fetal harm when administered &#116;&#111; &#097; pregnant woman. Women of child-bearing potential &#115;&#104;&#111;&#117;&#108;&#100; avoid becoming pregnant while taking Tasigna and &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; advised of the potential hazard &#116;&#111; the fetus if &#116;&#104;&#101;&#121; &#100;&#111;.</p>
<p><b>Adverse Reactions</b></p>
<p><b>Newly Diagnosed Ph+ CML-CP:</b></p>
<p>The most common (&gt;10%) non-hematologic Adverse Drug Reactions (ADRs) &#119;&#101;&#114;&#101; rash , pruritus , headache, nausea, fatigue, and myalgia . Upper abdominal pain, alopecia, constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain,  peripheral edema, and asthenia &#119;&#101;&#114;&#101; observed less commonly (<u>5%) and &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; mild &#116;&#111; moderate severity, manageable, and generally &#100;&#105;&#100; &#110;&#111;&#116; require dose reduction. Pleural and pericardial effusions occurred &#105;&#110; 1% of patients. Gastrointestinal hemorrhage &#119;&#097;&#115; reported &#105;&#110; 0.4% of patients. </p>
<p>The most common hematologic ADRs (all grades) &#119;&#101;&#114;&#101; myelosuppression including: thrombocytopenia (17%), neutropenia (15%), and anemia (7%). </p>
<p><b>Resistant &#111;&#114; Intolerant Ph+ CML-CP and CML-AP:</b></p>
<p>In chronic phase patients, the most commonly reported adverse drug reactions (&gt;10%) &#119;&#101;&#114;&#101; rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, and vomiting. The common &#115;&#101;&#114;&#105;&#111;&#117;&#115; drug-related adverse reactions &#119;&#101;&#114;&#101; thrombocytopenia and neutropenia. </p>
<p>In accelerated phase patients, the most commonly reported adverse drug reactions (&gt;10%) &#119;&#101;&#114;&#101; rash, pruritus, and constipation. The common &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse drug reactions &#119;&#101;&#114;&#101; thrombocytopenia, neutropenia, pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, elevated lipase and pyrexia. </p>
<p><b>Dose Adjustments &#111;&#114; Modifications  </b></p>
<p>Tasigna &#109;&#097;&#121; &#110;&#101;&#101;&#100; &#116;&#111; &#098;&#101; temporarily withheld and/or dose reduced &#102;&#111;&#114; QT prolongation, hematological toxicities that are &#110;&#111;&#116; related &#116;&#111; underlying leukemia, clinically significant moderate &#111;&#114; severe nonhematologic toxicities, laboratory abnormalities, &#111;&#114; concomitant &#117;&#115;&#101; of strong CYP3A4 inhibitors. </p>
<p>For Grade 3 &#116;&#111; 4 lipase elevations, dosing &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; withheld, and &#109;&#097;&#121; &#098;&#101; resumed at 400 mg &#111;&#110;&#099;&#101; daily. &#102;&#111;&#114; Grade 3 &#116;&#111; 4 bilirubin &#111;&#114; hepatic transaminase elevations, dosing &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; withheld, and &#109;&#097;&#121; &#098;&#101; resumed at 400 mg &#111;&#110;&#099;&#101; daily. </p>
<p><u><i>Hepatic impairment</i></u></p>
<p>If &#112;&#111;&#115;&#115;&#105;&#098;&#108;&#101;, &#099;&#111;&#110;&#115;&#105;&#100;&#101;&#114; alternative therapies. If Tasigna &#109;&#117;&#115;&#116; &#098;&#101; administered &#116;&#111; patients with hepatic impairment, &#097; &#108;&#111;&#119;&#101;&#114; starting dose is recommended &#105;&#110; patients with hepatic impairment and QT interval &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; monitored. The following dose reduction &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; considered:</p>
<p><u><i>Newly diagnosed Ph+ CML-CP</i></u></p>
<p>For patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) , &#097;&#110; initial dosing regimen of 200 mg twice daily followed &#098;&#121; dose escalation &#116;&#111; 300 mg twice daily based &#111;&#110; tolerability.  </p>
<p><u><i>Resistant &#111;&#114; intolerant Ph+ CML-CP and CML-AP</i></u></p>
<p>For patients with mild (Child-Pugh Class A) &#111;&#114; moderate (Child-Pugh Class B) hepatic impairment, &#097;&#110; initial dosing regimen of 300 mg twice daily followed &#098;&#121; dose escalation &#116;&#111; 400 mg twice daily based &#111;&#110; tolerability &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; considered. &#102;&#111;&#114; patients with severe hepatic impairment (Child-Pugh Class C), &#097; starting dose of 200 mg twice daily followed &#098;&#121; &#097; sequential dose escalation &#116;&#111; 300 mg twice daily and then &#116;&#111; 400 mg twice daily based &#111;&#110; tolerability &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; considered.</p>
<p><b>Other Patients &#105;&#110; &#119;&#104;&#111;&#109; Tasigna &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; &#117;&#115;&#101;&#100; with Caution </b></p>
<p>Tasigna &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101; &#117;&#115;&#101;&#100; &#100;&#117;&#114;&#105;&#110;&#103; pregnancy. Sexually active female patients &#115;&#104;&#111;&#117;&#108;&#100; &#117;&#115;&#101; effective contraception &#100;&#117;&#114;&#105;&#110;&#103; treatment. Women &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; breast feed while taking Tasigna. The safety and effectiveness of Tasigna &#105;&#110; pediatric patients &#104;&#097;&#118;&#101; &#110;&#111;&#116; &#098;&#101;&#101;&#110; established.</p>
<p>Please &#115;&#101;&#101; accompanying &#102;&#117;&#108;&#108; prescribing information.</p>
<p><b>About Gleevec </b>(7)</p>
<p>Gleevec® (imatinib mesylate) tablets are indicated &#102;&#111;&#114; newly diagnosed adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) &#105;&#110; the chronic phase (CP). Gleevec is &#097;&#108;&#115;&#111; indicated &#102;&#111;&#114; the treatment of patients with Ph+ CML &#105;&#110; blast crisis (BC), accelerated phase (AP), &#111;&#114; &#105;&#110; CP &#097;&#102;&#116;&#101;&#114; failure of interferon-alpha therapy.</p>
<p><b>Who &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; Take Gleevec</b></p>
<p>Gleevec &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101; taken &#098;&#121; women who are &#111;&#114; could &#098;&#101; pregnant. Fetal harm &#099;&#097;&#110; occur when administered &#116;&#111; pregnant women; &#116;&#104;&#101;&#114;&#101;&#102;&#111;&#114;&#101;, women &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101;&#099;&#111;&#109;&#101; pregnant, &#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; &#098;&#101; advised of the potential risk &#116;&#111; the unborn child if Gleevec is &#117;&#115;&#101;&#100; &#100;&#117;&#114;&#105;&#110;&#103; pregnancy. Gleevec &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; &#110;&#111;&#116; &#098;&#101; taken &#098;&#121; women who are breast-feeding because of the potential &#102;&#111;&#114; &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse reactions &#105;&#110; nursing infants. Sexually active females &#115;&#104;&#111;&#117;&#108;&#100; &#117;&#115;&#101; adequate birth control while taking Gleevec.</p>
<p>Be sure &#116;&#111; talk &#116;&#111; your doctor and/or healthcare professional about these issues &#098;&#101;&#102;&#111;&#114;&#101; taking Gleevec.</p>
<p><b>Warnings and Precautions</b></p>
<p>Gleevec is often associated with edema (swelling) and &#115;&#101;&#114;&#105;&#111;&#117;&#115; fluid retention. &#105;&#116; is &#105;&#109;&#112;&#111;&#114;&#116;&#097;&#110;&#116; that patients &#098;&#101; weighed and monitored regularly &#102;&#111;&#114; signs and symptoms of &#115;&#101;&#114;&#105;&#111;&#117;&#115; fluid retention, &#111;&#114; unexpected weight gain. Patients experiencing unexpected rapid weight gain &#115;&#104;&#111;&#117;&#108;&#100; speak &#116;&#111; &#116;&#104;&#101;&#105;&#114; doctor about appropriate supportive care treatment. Studies &#104;&#097;&#118;&#101; shown that edema (swelling) tended &#116;&#111; occur &#109;&#111;&#114;&#101; often among patients who are 65 and older &#111;&#114; &#116;&#104;&#111;&#115;&#101; taking higher doses of Gleevec. If &#121;&#111;&#117; experience severe fluid retention, your doctor &#109;&#097;&#121; &#115;&#116;&#111;&#112; your treatment with Gleevec until the fluid retention &#104;&#097;&#115; &#098;&#101;&#101;&#110; managed.</p>
<p>Cytopenias (reduction &#111;&#114; lack of &#099;&#101;&#114;&#116;&#097;&#105;&#110; cell elements &#105;&#110; blood circulation), &#115;&#117;&#099;&#104; &#097;&#115; anemia, &#104;&#097;&#118;&#101; occurred. Your doctor &#119;&#105;&#108;&#108; perform complete blood counts weekly &#102;&#111;&#114; the first month, biweekly &#102;&#111;&#114; the &#115;&#101;&#099;&#111;&#110;&#100; month, and periodically &#116;&#104;&#101;&#114;&#101;&#097;&#102;&#116;&#101;&#114;. &#105;&#110; most cases, your doctor &#119;&#105;&#108;&#108; reduce &#111;&#114; interrupt your Gleevec therapy; &#105;&#110; rare cases, your doctor &#109;&#097;&#121; discontinue treatment. If the cytopenia is severe, your doctor &#109;&#097;&#121; reduce your dose &#111;&#114; temporarily &#115;&#116;&#111;&#112; your treatment with Gleevec.</p>
<p>Severe congestive heart failure and left ventricle dysfunction &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported, &#112;&#097;&#114;&#116;&#105;&#099;&#117;&#108;&#097;&#114;&#108;&#121; &#105;&#110; patients with &#111;&#116;&#104;&#101;&#114; health issues and risk factors. Patients with heart disease &#111;&#114; risk factors &#119;&#105;&#108;&#108; &#098;&#101; monitored and treated &#102;&#111;&#114; the condition.</p>
<p>Severe liver problems (hepatotoxicity) &#109;&#097;&#121; occur. Your doctor &#119;&#105;&#108;&#108; check your liver function &#098;&#101;&#102;&#111;&#114;&#101; beginning treatment and continue &#116;&#111; monitor liver function &#097;&#115; needed. If &#121;&#111;&#117; experience severe liver problems, your doctor &#109;&#097;&#121; &#115;&#116;&#111;&#112; your treatment with Gleevec until the liver problem &#104;&#097;&#115; &#098;&#101;&#101;&#110; managed.</p>
<p>Bleeding &#109;&#097;&#121; occur. Severe gastrointestinal (GI) bleeding &#104;&#097;&#115; &#098;&#101;&#101;&#110; reported &#105;&#110; patients with Ph+ CML.</p>
<p>In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are &#097; type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; associated with the initiation of Gleevec therapy. Speak &#116;&#111; your doctor regarding appropriate supportive care &#111;&#114; discontinuing Gleevec.</p>
<p>Skin reactions, &#115;&#117;&#099;&#104; &#097;&#115; fluid-filled blisters, &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported with the &#117;&#115;&#101; of Gleevec.</p>
<p>Clinical cases of hypothyroidism (reduction &#105;&#110; thyroid hormones) &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported &#105;&#110; patients taking levothyroxine replacement &#100;&#117;&#114;&#105;&#110;&#103; treatment with Gleevec. Your doctor &#115;&#104;&#111;&#117;&#108;&#100; closely monitor your thyroid hormone levels.</p>
<p>Long-term &#117;&#115;&#101; &#109;&#097;&#121; result &#105;&#110; potential liver, kidney, and/or heart toxicities; immune system suppression &#109;&#097;&#121; &#097;&#108;&#115;&#111; result from long-term &#117;&#115;&#101;.</p>
<p>Gleevec &#099;&#097;&#110; &#099;&#097;&#117;&#115;&#101; fetal harm when administered &#116;&#111; &#097; pregnant woman. Women &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; aware of the potential harm &#116;&#111; the fetus. &#098;&#101; sure &#116;&#111; inform your doctor if &#121;&#111;&#117; are &#111;&#114; think &#121;&#111;&#117; &#109;&#097;&#121; &#098;&#101; pregnant. &#121;&#111;&#117; &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; breast-feed while taking Gleevec.</p>
<p>GI perforation (small holes &#111;&#114; tears &#105;&#110; the walls of the stomach &#111;&#114; intestine), &#105;&#110; &#115;&#111;&#109;&#101; cases fatal, &#104;&#097;&#115; &#098;&#101;&#101;&#110; reported.</p>
<p><b>Gleevec &#105;&#109;&#112;&#111;&#114;&#116;&#097;&#110;&#116; Safety Information</b></p>
<p>The following &#115;&#101;&#114;&#105;&#111;&#117;&#115; side effects &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported &#105;&#110; patients taking Gleevec: severe fluid retention, (which &#099;&#097;&#110; &#099;&#097;&#117;&#115;&#101; swelling around the eyes &#111;&#114; swelling of the &#108;&#111;&#119;&#101;&#114; legs, lungs, and heart; fatal &#105;&#110; rare cases), increased pressure &#105;&#110; the heart &#111;&#114; brain (fatal &#105;&#110; rare cases), low levels of &#099;&#101;&#114;&#116;&#097;&#105;&#110; blood cells, heart failure/cardiogenic shock, liver problems, hemorrhage (abnormal bleeding), skin blistering and low levels of thyroid hormone. </p>
<p>Your doctor &#119;&#105;&#108;&#108; check &#121;&#111;&#117; closely &#102;&#111;&#114; any side effects &#116;&#111; &#115;&#116;&#111;&#112; &#109;&#111;&#114;&#101; &#115;&#101;&#114;&#105;&#111;&#117;&#115; complications from occurring. Patients with heart disease &#111;&#114; risk factors &#102;&#111;&#114; heart failure &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; &#098;&#101; monitored carefully.  </p>
<p>Gleevec is sometimes associated with stomach &#111;&#114; intestinal irritation. Gleevec &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; taken with food and &#097; large glass of water &#116;&#111; minimize &#116;&#104;&#105;&#115; problem. &#116;&#104;&#101;&#114;&#101; &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; rare reports, including deaths, of stomach &#111;&#114; intestinal perforation (a small hole &#111;&#114; tear).</p>
<p>If &#121;&#111;&#117; are experiencing any of the above-mentioned side effects, please &#098;&#101; sure &#116;&#111; speak with your doctor immediately.</p>
<p><b>Common Side Effects of Gleevec</b></p>
<p>Almost all patients treated with Gleevec experience side effects at &#115;&#111;&#109;&#101; time. Most side effects are mild &#116;&#111; moderate &#105;&#110; severity. &#115;&#111;&#109;&#101; common side effects &#121;&#111;&#117; &#109;&#097;&#121; experience include fluid retention, muscle cramps &#111;&#114; pain and bone pain, vomiting, diarrhea, decreased hemoglobin, nausea, fatigue, rash and anorexia (loss of appetite). </p>
<p>If &#121;&#111;&#117; are experiencing any of the above-mentioned side effects, please &#098;&#101; sure &#116;&#111; speak with your doctor immediately.</p>
<p>The severity of &#115;&#111;&#109;&#101; side effects &#109;&#097;&#121; &#098;&#101; reduced with the &#104;&#101;&#108;&#112; of &#111;&#116;&#104;&#101;&#114; medicines and advice from your doctor, while &#111;&#116;&#104;&#101;&#114;&#115; &#109;&#097;&#121; require &#115;&#116;&#111;&#112;&#112;&#105;&#110;&#103; Gleevec therapy &#102;&#111;&#114; &#097; while &#111;&#114; changing the dose. However, &#105;&#110; &#115;&#111;&#109;&#101; cases, Gleevec therapy &#109;&#097;&#121; &#110;&#101;&#101;&#100; &#116;&#111; &#098;&#101; discontinued.  </p>
<p>Tell your doctor if &#121;&#111;&#117; experience side effects &#100;&#117;&#114;&#105;&#110;&#103; therapy with Gleevec, including fever, shortness of breath, blood &#105;&#110; your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, symptoms of heart failure, &#111;&#114; if &#121;&#111;&#117; &#104;&#097;&#118;&#101; &#097; history of heart disease &#111;&#114; risk factors &#102;&#111;&#114; heart disease. </p>
<p>After the approval of Gleevec, the following adverse events &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; reported &#105;&#110; patients treated with Gleevec: compression of the heart due &#116;&#111; increased fluid, swelling of the brain, GI perforation (holes &#105;&#110; the stomach &#111;&#114; intestine), and sudden lung failure. These events, including &#115;&#111;&#109;&#101; fatalities, &#109;&#097;&#121; &#111;&#114; &#109;&#097;&#121; &#110;&#111;&#116; &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; drug related.  </p>
<p>Take Gleevec exactly &#097;&#115; prescribed. &#100;&#111; &#110;&#111;&#116; change your dose &#111;&#114; &#115;&#116;&#111;&#112; taking Gleevec unless &#121;&#111;&#117; are &#116;&#111;&#108;&#100; &#116;&#111; &#100;&#111; &#115;&#111; &#098;&#121; your doctor. If &#121;&#111;&#117; &#109;&#105;&#115;&#115; &#097; dose, take your dose &#097;&#115; &#115;&#111;&#111;&#110; &#097;&#115; &#112;&#111;&#115;&#115;&#105;&#098;&#108;&#101;, unless &#105;&#116; is almost time &#102;&#111;&#114; your &#110;&#101;&#120;&#116; dose. &#105;&#110; &#116;&#104;&#105;&#115; case, your missed dose &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101; taken. &#097; double dose &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; &#098;&#101; taken &#116;&#111; &#109;&#097;&#107;&#101; &#117;&#112; &#102;&#111;&#114; any missed dose. &#121;&#111;&#117; &#115;&#104;&#111;&#117;&#108;&#100; take Gleevec with &#097; meal and &#097; large glass of water.  </p>
<p>Do &#110;&#111;&#116; take any &#111;&#116;&#104;&#101;&#114; medications &#119;&#105;&#116;&#104;&#111;&#117;&#116; talking &#116;&#111; your doctor &#111;&#114; pharmacist first, including over-the-counter medications &#115;&#117;&#099;&#104; &#097;&#115; Tylenol® (acetaminophen); herbal products (St. John&#8217;s wort, Hypericum perforatum); Coumadin® (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin® (phenytoin). Taking these with Gleevec &#109;&#097;&#121; affect how &#116;&#104;&#101;&#121; work, &#111;&#114; affect how Gleevec works.  </p>
<p>You &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; tell your doctor if &#121;&#111;&#117; are taking &#111;&#114; plan &#116;&#111; take iron supplements. Patients &#115;&#104;&#111;&#117;&#108;&#100; &#097;&#108;&#115;&#111; avoid grapefruit juice and &#111;&#116;&#104;&#101;&#114; foods that &#109;&#097;&#121; affect how Gleevec works. </p>
<p>Tylenol (acetaminophen) is &#097; registered trademark of McNeil Consumer &amp; Specialty Pharmaceuticals, &#097; division of McNeil PPC, Inc. Coumadin (warfarin sodium) is &#097; registered trademark of Bristol-Myers Squibb Company. Dilantin (phenytoin) is &#097; registered trademark of Parke-Davis, &#097; division of Pfizer Inc.</p>
<p>*For &#109;&#111;&#114;&#101; detailed study information, please &#115;&#101;&#101; &#102;&#117;&#108;&#108; Prescribing Information.</p>
<p><b>Disclaimer</b></p>
<p>The foregoing release &#099;&#111;&#110;&#116;&#097;&#105;&#110;&#115; forward-looking statements that &#099;&#097;&#110; &#098;&#101; identified &#098;&#121; terminology &#115;&#117;&#099;&#104; &#097;&#115; &#8220;under review,&#8221; &#8220;expected,&#8221; &#8220;goal,&#8221; &#111;&#114; similar expressions, &#111;&#114; &#098;&#121; express &#111;&#114; implied discussions regarding potential new indications &#111;&#114; labeling &#102;&#111;&#114; Tasigna &#111;&#114; regarding potential future revenues from Tasigna &#111;&#114; Gleevec. &#121;&#111;&#117; &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; place undue reliance &#111;&#110; these statements. &#115;&#117;&#099;&#104; forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and &#111;&#116;&#104;&#101;&#114; factors that &#109;&#097;&#121; &#099;&#097;&#117;&#115;&#101; actual results with Tasigna &#111;&#114; Gleevec &#116;&#111; &#098;&#101; materially different from any future results, performance &#111;&#114; achievements expressed &#111;&#114; implied &#098;&#121; &#115;&#117;&#099;&#104; statements. &#116;&#104;&#101;&#114;&#101; &#099;&#097;&#110; &#098;&#101; no guarantee that Tasigna &#119;&#105;&#108;&#108; &#098;&#101; approved &#102;&#111;&#114; any additional indications &#111;&#114; labeling &#105;&#110; any market. &#110;&#111;&#114; &#099;&#097;&#110; &#116;&#104;&#101;&#114;&#101; &#098;&#101; any guarantee that Tasigna &#111;&#114; Gleevec &#119;&#105;&#108;&#108; achieve any &#112;&#097;&#114;&#116;&#105;&#099;&#117;&#108;&#097;&#114; levels of revenue &#105;&#110; the future. &#105;&#110; &#112;&#097;&#114;&#116;&#105;&#099;&#117;&#108;&#097;&#114;, management&#8217;s expectations regarding Tasigna and Gleevec could &#098;&#101; affected &#098;&#121;, among &#111;&#116;&#104;&#101;&#114; things, unexpected regulatory actions &#111;&#114; delays &#111;&#114; government regulation generally;  unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company&#8217;s ability &#116;&#111; obtain &#111;&#114; maintain patent &#111;&#114; &#111;&#116;&#104;&#101;&#114; proprietary intellectual property protection; competition &#105;&#110; general; government, industry and general public pricing pressures; the impact that the foregoing factors could &#104;&#097;&#118;&#101; &#111;&#110; the values attributed &#116;&#111; the Novartis Group&#8217;s assets and liabilities &#097;&#115; recorded &#105;&#110; the Group&#8217;s consolidated balance sheet, and &#111;&#116;&#104;&#101;&#114; risks and factors referred &#116;&#111; &#105;&#110; Novartis AG&#8217;s current Form 20-F &#111;&#110; file with the US Securities and Exchange Commission. &#115;&#104;&#111;&#117;&#108;&#100; one &#111;&#114; &#109;&#111;&#114;&#101; of these risks &#111;&#114; uncertainties materialize, &#111;&#114; &#115;&#104;&#111;&#117;&#108;&#100; underlying assumptions prove &#105;&#110;&#099;&#111;&#114;&#114;&#101;&#099;&#116;, actual results &#109;&#097;&#121; vary materially from &#116;&#104;&#111;&#115;&#101; anticipated, believed, estimated &#111;&#114; expected. Novartis is providing the information &#105;&#110; &#116;&#104;&#105;&#115; press release &#097;&#115; of &#116;&#104;&#105;&#115; date and does &#110;&#111;&#116; undertake any obligation &#116;&#111; update any forward-looking statements contained &#105;&#110; &#116;&#104;&#105;&#115; press release &#097;&#115; &#097; result of new information, future events &#111;&#114; &#111;&#116;&#104;&#101;&#114;&#119;&#105;&#115;&#101;.</p>
<p><b>About Novartis</b></p>
<p>Located &#105;&#110; East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is &#097;&#110; affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely &#111;&#110; healthcare, the Novartis Group offers &#097; diversified portfolio &#116;&#111; &#098;&#101;&#115;&#116; meet these needs: innovative medicines, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals and consumer health products. The Novartis Group is the &#111;&#110;&#108;&#121; company with leading positions &#105;&#110; &#101;&#097;&#099;&#104; of these areas. &#105;&#110; 2009, the Group&#8217;s continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion &#119;&#097;&#115; invested &#105;&#110; R&amp;D activities throughout the Group. Headquartered &#105;&#110; Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate &#105;&#110; &#109;&#111;&#114;&#101; &#116;&#104;&#097;&#110; 140 countries around the world. &#102;&#111;&#114; &#109;&#111;&#114;&#101; information, please visit us.novartis.com.</p>
<p>Novartis is &#111;&#110; Twitter. Sign &#117;&#112; &#116;&#111; follow @Novartis at twitter.com/novartis.</p>
<p>* Known &#097;&#115; Glivec® (imatinib) &#111;&#117;&#116;&#115;&#105;&#100;&#101; the US, Canada and Israel.</p>
<p><b>References </b></p></p>
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